1. Field of the Invention.
The subject invention relates to a connector assembly for a vial, and more particularly, to a connector assembly for a vial which can be safely removed from the vial after use to facilitate the disposal of the various components.
2. Description of the Prior Art.
Many drugs are presented in dry form to achieve a longer shelf life. These drugs are reconstituted by a suitable solvent into liquid form for delivery to a patient. One type of dry drug is a lyophilized drug.
In the art, there are a number of ways to store dry drugs such as lyophilized drugs in a form conducive to reconstitution and delivery. Some of these products are exemplified, for example, by the MONOVIAL .RTM.-brand prefillable drug delivery devices manufactured and sold by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France. Such systems are further exemplified, for instance, in U.S. Pat. No. 5,358,501, issued to Gabriel Meyer on Oct. 25, 1994. While there are variations of such systems, in general, they feature vials made of glass or suitable plastic materials, in which a selected dose of a lyophilized drug may be stored. The vial is generally sealed to prevent deterioration or contamination of the drug. The dry drug may be reconstituted with a liquid solvent shortly prior to use, and the now reconstituted drug solution may be administered to a patient.
Various components are employed with the prefillable drug-delivery systems described above. For instance, the vials are typically provided with a vial connector assembly to enable attachment of the vial to a source of solvent to reconstitute the dry drug. The same vial connector is also normally used to attach the vial to an intravenous fitting to deliver the reconstituted drug to a patient. Vial connectors such as used with the prefillable drug delivery systems described above typically include one or more components necessary for the function of the system. For instance, one or more rubber stopper or membrane components are provided to seal the vial until such time as access to the drug, in its dry or liquid form, is desired. A fluid transfer device, such as a needle or spike, is also provided, both to provide means for introducing solvent into the vial and for delivering the reconstituted drug out of the vial. Generally, a collar component is provided adjacent the rim of the vial to secure the various parts, such as the fluid transfer device and the sealing components, associated with the vial connector.
Depending on the configuration of the prefillable drug-delivery system, the system might be activated by moving the collar relative to the vial rim, wherein the fluid transfer device and sealing components are fixed relative to the collar, or by moving the fluid transfer device and sealing components relative to the vial, wherein the collar is fixed relative to the vial rim movable manner relative to the collar. Accordingly, depending on the configuration, the system can be activated either by causing motion between the collar and the rim, or by causing motion between the fluid transfer device and/or sealing components relative to the collar.
One aspect of the aforementioned systems is that subsequent to use, the various components, such as the fluid transfer device, sealing components, and the collar itself remain fixed to the vial. Here, once the drug has been delivered to the patient, the entire system is disposed of whole in a sterile manner. Owing to the different materials used for the various components, benefits may be realized in configuring a system wherein the components can be separated from one another in a safe manner to facilitate disposal. For instance, certain governmental regulations or accepted practices may encourage disposing of the vial, which contained the drug in its dry and reconstituted forms, separately from the transfer assembly.